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A comparison of the accuracies of ultrasound and magnetic resonance imaging in assessing the spread of womb cancer

A prospective comparison of the diagnostic accuracies of ultrasound and magnetic resonance imaging in preoperative staging of endometrial cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN24363390
Enrollment
49
Registered
2021-08-06
Start date
2015-10-07
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoperative diagnoses of deep myometrial invasion and cervical stromal invasion in women with endometrial cancer Cancer Malignant neoplasm: Endometrium

Interventions

Consecutive women presenting with postmenopausal bleeding to our gynaecology outpatient clinic during the study period are potentially eligible. Women who have previously undergone a

Sponsors

University College London Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Postmenopausal women (at least 45 years of age with at least 1 year of amenorrhea) 2. Presenting with postmenopausal bleeding, including women with unscheduled bleeding whilst on hormone replacement therapy

Exclusion criteria

Exclusion criteria: 1. Women with a previous history of hysterectomy 2. Women with a known diagnosis of gynaecological malignancy 3. Women who decline a transvaginal or transrectal ultrasound scan 4. Women who have a contraindication to MRI scan 5. Women who are managed expectantly (without hysterectomy) following a diagnosis of endometrial cancer

Design outcomes

Primary

MeasureTime frame
At a single time point: The diagnostic accuracies of ultrasound and MRI for DMI and CSI in endometrial cancer 1. Sensitivity measured using the findings from the respective imaging test with histology as the reference standard. 2. Specificity measured using the findings from the respective imaging test with histology as the reference standard. 3. Positive likelihood ratio measured using the findings from the respective imaging test with histology as the reference standard. 4. Negative likelihood ratio measured using the findings from the respective imaging test with histology as the reference standard. 5. Overall accuracy measured using the findings from the respective imaging test with histology as the reference standard.

Secondary

MeasureTime frame
At a single time point: 1. The accuracy of ultrasound subjective pattern recognition in diagnosing endometrial cancer (sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and overall accuracy) measured using the findings on ultrasound scan with histology as the reference standard. 2. The number of unsatisfactory ultrasound assessments to diagnose and stage endometrial cancer amongst women with postmenopausal bleeding (as a proportion of the total number of women included in the study). 3. The efficacies of transrectal ultrasound scan and saline infusion sonography (as a proportion of the total number of unsatisfactory ultrasound assessments) measured using patient records.

Countries

England, United Kingdom

Contacts

Public ContactMichael Wong
michael.wong3@nhs.net+44 (0)20 3456 7890

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026